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Ondansetron Use for Preventing Pruritus in Patients Undergoing Cesarean Section

StatusRecruiting
PhasePhase 1
Started
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Record status
This record was last updated March 28, 2025 (before its estimated August 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2024 to Aug 22, 2024
    • Site details revised
    v4
  2. Primary completion date: Aug 1, 2024 to Aug 1, 2025
    • Start date: Mar 2024 to Aug 2024
    • Study completion date: Dec 1, 2024 to Dec 1, 2025
    v3
  3. Eligibility criteria revised
    • Secondary endpoints: details revised at 1 of 1 entry
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Opioids are often added with a local anesthetic to enhance the duration and quality of spinal anesthesia for cesarean delivery patients. However, spinal opioids are associated with a wide variety of side effects such as nausea, vomiting, (N/V) and pruritus (itching). The occurrence of pruritus can vary between 30% and 100% making pruritus the most common side-effect of intrathecal opioids and this rate is even higher in pregnant patients. Pruritus may require treatment which can be ineffective or sometimes reverse the analgesic effect of the opioids. Ondansetron is a safe and very commonly used Serotonin receptor antagonist treatment for local anesthetic opioid-induced pruritus used in pregnancy. The effect of different administration times of ondansetron in reducing pruritus or N/V in cesarean section (CS) cases has not been extensively studied and thus, this prospective study can help guide future clinical management of side effects caused by spinal intrathecal morphine administration.
Trial Details
NCT Number NCT06297499
Lead Sponsor Wayne State University
Conditions
(from sponsor)		 Pruritus Caused by Drug
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov